Pancreatic Cancer
Conditions
Interventions
Product Name: CP-4126 for infusion
Product Code: CP-4126
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: 210829-30-4
Current Sponsor code: CP-4126
Other
Sponsors
Clavis Pharma ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological confirmed advanced pancreatic cancer* 2. Not eligible for curative resection 3. Performance status (ECOG) 0-2 4. Estimated life expectancy of at least 12 weeks 5. Age = 18 years 6. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils = 1.5 x 109/L b. Platelets > 100.0 x 109/L c. Hb = 10 g/dL • Hepatic function: a. AST/ALT and alkaline phosphatase (ALP) = 2.5 x institutional upper limit of normal (ULN), if liver metastases; AST/ALT = 5 x institutional ULN and ALP = 4 x institutional ULN b. Bilirubin = 1.5 times institutional ULN, if liver metastases = 3 x institutional ULN • Renal function: a. Serum creatinine = 1.5 times institutional ULN 7. Signed informed consent *When feasible, the biopsy for diagnosis and hENT1 can be combined, so that the patient only needs to have one biopsy performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for metastatic disease 2. Symptomatic brain metastases 3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study 4. Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs 5. History of allergic reactions to gemcitabine or egg 6. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection) 7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 8. Pregnant or breastfeeding women 9. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment 10. Known positive status for HIV 11. Any reason why, in the investigator’s opinion, the patient should not participate in the study. 12. Drug or alcohol abuse 13. Prior radical resection, but exploratory laparotomy as well palliative (e.g. bypass) surgery are allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. ;Secondary Objective: Additional objectives is to assess - the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival - safety profile ;Primary end point(s): • Overall survival (OS); relation between hENT1 expression level and survival • Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumours (RECIST) in patients with measurable disease. Changes in the tumour marker, CA19-9 will also be considered. • Safety profile • Feasibility: patient acceptance, biopsy sampling and analysis | — |
Countries
France, Sweden
Outcome results
None listed